NCT02783248

French National Observatory of Percutaneous Mitral Commissurotomy

French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 301 (actual)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

Detailed description

This is a multicenter prospective observational study conducted in French medico-surgical sites. The Percutaneous Mitral Commissurotomy (PMC) is the standard treatment for Mitral stenosis (MS) in patients with rheumatic favorable characteristics. In Western countries the MS reaches older patients with less favorable characteristics, including the presence of mitral calcifications. Calcifications are a factor of poor outcome of the PMC. The scanner appears as a useful examination for their study but is not carried out systematically. The prediction of late results of the PMC is particularly important in patients with non-ideal characteristics which form a particularly heterogeneous population. A score of late results of the PMC on the wider western series was recently released but has not to date received external validation. In this score, prediction results was multifactorial, with a consideration of paramount clinical factors, but also a prognostic significance of mitral calcifications. The validation of predictive score of late results of the PMC, with the analysis of calcifications, would better select patients who may best benefit from PMC and those for which the surgical management is preferred. The aim of this study is to validate an external sample predictive score of the event-free survival in patients who have had a good immediate result of the PMC. This study, purely observational, does not create any special procedure outside the patient's usual care.

Conditions

• Mitral Stenosis

Timeline

• Start date: 2016-06-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2016-05-26
• Last updated: 2022-09-21

Locations

1 site across 1 country: France